ONWARD Reports Positive Topline Results from a Pivotal Study to Restore Arm and Hand Function in People with Spinal Cord Injury
Up-LIFT study achieves primary endpoint: Statistically significant and clinically meaningful improvement in upper extremity strength and function
Improvement in arm and hand function is the highest priority among people with tetraplegia
ONWARD plans to submit for marketing approval in the U.S. and Europe with the goal to launch ARC-EX Therapy in the second half of 2023
EINDHOVEN, the Netherlands, LAUSANNE, Switzerland, and BOSTON, MA USA—September 13, 2022--ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative therapies to restore movement, independence, and health in people with spinal cord injury (SCI), today announced that the Up-LIFT pivotal study evaluating ARC-EX Therapy achieved its primary effectiveness endpoint of improvement in upper extremity strength and function. ARC-EX Therapy is a proprietary non-invasive spinal cord stimulation technology designed to restore movement and other functions in people with movement disabilities.
“The Up-LIFT study results represent a turning point in the field of spinal cord injury and paralysis science,” said Marco Baptista, Ph.D., Chief Scientific Officer of the Christopher & Dana Reeve Foundation. Functional recovery once deemed impossible may now be in reach. The Reeve Foundation looks forward to this technology advancing and, we hope, becoming widely available to our community.”
"Our vision is to empower people with spinal cord injury to enjoy life in every way that matters to them. Today's excellent results from the Up-LIFT study will help us transform that vision into reality", said Dave Marver, ONWARD CEO. " Our team is working hard to prepare regulatory submissions and to get ready for launch in the U.S. and Europe. We are hopeful we can begin to positively impact the lives of people with spinal cord injury sometime during the second half of 2023."
"Restoring hand and arm function after spinal cord injury is life-changing, freeing people with paralysis to feed and care for themselves and be more independent every day activities," said Chet Moritz, Ph.D., study co-Principal Investigator (co-PI) and Professorr of Electrical & Computer Engineering and Rehabilitation Medicine at the University of Washington.
"We are grateful to the many therapists, clinicians, and people with SCI who participated in this landmark study. There was very low attrition over thousands of clinic visits, a testament to the collective enthusiasm for this compelling therapy and for everyone's determination to find new treatment options for people with SCI, added Edelle Field-Fote, PT, Ph.D., FAPTA,FASIA, study co-PI, Director of SCI Research at the Shepherd Center in Atlanta, GA, and Professor at Emory University School of Medicine in the Department of Rehabilitation Medicine.
The Up-LIFT study is a prospective, single-arm pivotal study designed to evaluate the safety and effectiveness of non-invasive electrical spinal cord stimulation (ARC-EX Therapy) to treat upper extremity functional deficits in people with chronic tetraplegia (paralysis of all four limbs). The study enrolled 65 people at 14 leading SCI centers in the U.S., Europe, and Canada. Time since injury averaged 5.9 years (range 1 to 34 years) with an average subject age of 46.5 years. Detailed results will be made available after review by the FDA. The company plans to submit for regulatory approval in both the US and Europe within the next 6 months.
Participants completed an average of 50 training sessions over a period of about 4 months. A series of comprehensive assessments were performed at baseline and monthly thereafter to detect changes in sensory and motor function of upper extremities that directly translate into improved functional performance in activities of daily living. Rigorous measures such as CUE-T, GRASSP, ISNCSCI and pinch and grasp fore were used to detect clinically meaningful changes resulting from the combination of ONWARD ARC-EX Therapy with a standard of care rehabilitation. An independent data safety monitoring board adjudicated the safe conduct of the study.
About Spinal Cord Injury
Spinal cord injury (SCI) represents a major unmet medical need for which there is no cure. Approximately 7 million people globally have a spinal cord injury, with over 650,000 in the U.S. and Europe alone. The quality of life of people with SCI can be poor, with paralysis and loss of incontinence, and loss of sexual function. Assistance is required for daily living acitivities. And SCI is costly, with the average lifetime cost for a paraplegic (paralysis of the legs) of $2.5 million and $5 million for a tetraplegic (paralysis of all four limbs). Treatments are urgently needed to restore movement and improve quality of life.
For further information regarding this press release, please visit ONWD.com.« back to overview